CLI Mortality Rates
exceed those for every other form of occlusive cardiovascular disease, including symptomatic coronary artery disease (CAD), and reflect the systemic atherosclerotic burden associated with CLI.2

CLI is not to be confused with acute occlusion of the distal arterial tree, but rather a disease process that occurs in a chronic setting of months to years and, if left untreated, ultimately leads to limb loss secondary to lack of adequate blood flow and oxygenation through the distal extremities.1

Given that CLI is a severe manifestation of PAD, these patients would be classified in the more severe ends of the Fontaine classification (stage III-IV) or the Rutherford classification.1

CLI is associated with poor quality of life and high treatment costs, especially when amputation is inevitable2

Besides poor survival rates, prognosis with respect to limb preservation in CLI patients is poor, particularly in no-option CLI patients, where 6-month major amputation rates have been reported to be as high as 50%.2

More can be done to help prevent CLI treatment from becoming the precursor to amputation.

Impact of current PAD/CLI disease on amputations

PAD AND CLI affected 215 million people worldwide in 2015, predicted to be 230 million by 20203

Nearly 18 million U.S. citizens suffer from PAD—projected to increase to 24 million by 2030.4

CLI currently afflicts 2.8 to 3.5 million of those diagnosed with PAD. This is projected to rise to 4.5 to 5.6 million by 2030.4

An estimated 25% of CLI patients will undergo amputation.

Amputations due to CLI could reach one million by 2030.

Approximately 65,000 to 70,000 major amputations are currently performed for PAD, and almost all of these patients suffer from CLI.5

The key to the future of successful outcomes in BTK/PVI vs. surgical intervention

The key for the future of successful outcomes in BTK/PVI vs. surgical could depend on several factors:

Specific patient selection criteria: the ability to select patients likely to benefit over medical therapy and experience outcomes comparable to surgical intervention or the ability to determine optimal criteria for what constitutes a salvageable limb6

Point of access: the access to BTK intervention that originates BTK, particularly with pedal/tibial access points

Restenosis: the ability to reduce restenosis rates or new de novo disease that can limit long-term outcomes6

Advances in minimally invasive CLI treatment

Rates of amputations in the general population with PAD/CLI

Amputations in the overall PAD population are declining, but despite recent advances, amputations in CLI continue to be a primary procedure1

Patients with CLI arereferred late
in their course1

There is no agreed-upon definition of anon-salvageable limb6

There are stillnot enough viable device options
small enough for BTK to make PVI
(peripheral vascular intervention) a first-line choice

The pace of development of endovascular, minimally invasive techniques will be much faster than any other improvement in surgical techniques. I do believe that sometime in the future minimally invasive catheter techniques could potentially become the mainstay of therapy.

Complication rate of CLI amputation

The 20% to 37% major complication rate associated with amputation is considerably higher than the 16% to 17% average for vascular surgery and the average of 5% to 9% for endovascular surgery.2

20%–37%
MAJOR COMPLICATION RATE FOR AMPUTATION

16%–17%
MAJOR COMPLICATION RATE FOR VASCULAR SURGERY

5%–9%
MAJOR COMPLICATION RATE FOR ENDOVASCULAR SURGERY

Less invasive methods of CLI intervention

There is a strong trend in every single area of cardiovascular and endovascular medicine toward the use of less invasive methods and toward more minimally invasive approaches. Catheters are becoming easier to use, smaller in size, and more sophisticated, facilitating the delivery of therapies and rapid recovery of patients.

Rapid development of less invasive techniques and devices

Endovascular, minimally invasive techniques for the treatment of Peripheral Vascular Disease (PVD), PAD and CLI are being developed very rapidly. At some point in the near future, they could have the potential to overtake the development of surgical techniques.

The next step is already happening, with the development of smaller micro stents, drug-eluting balloons, sub-4Fr guidewires, new fully integrated micro-intervention systems, and innovative devices providing pedal access for BTK lesions.